Impact of an APA Program on EFS in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line

NCT ID: NCT04670029

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-08
• Study Completion Date: 2029-02-28

Brief Summary

Diffuse large B cell lymphoma is the most common histology of non-Hodgkin's malignant lymphomas (31% of lymphomas), with an incidence of between 15 and 20 new cases per year per 100,000 inhabitants in France. The median age is 65 and a third of patients are over 75 years old. 60% of patients are cured after a standard regimen of chemotherapy with RCHOP; 40% of patients will, however, relapse. No other regimen has shown improvement in overall survival, but poor prognosis factors have been identified. Beyond these factors, other prognostic factors can impact overall and progression-free survival: sarcopenia, nutritional status disorders Sarcopenia is defined by the reduction of muscle mass and strength. It was first described in the elderly and classified as geriatric syndrome such as dementia, falls or frailty. It varies from 5 to 13% between 60 and 70 years and between 11 and 50% beyond 80 years and is classified as primitive, that is to say related to age It can however be secondary to neoplasia. This event has been described in patients with hematologic malignancies during chemotherapy and can reach 55% of patients in the elderly. It is proportional to the intensity of the treatments. It emerges as an independent prognostic factor which is detrimental to survival in these patients. Physical exercise combined with nutritional support could reduce it.

The positive impact of adapted physical activity has been shown in numerous publications on reducing the incidence and risk of relapse for certain cancers (breast, colon prostate). It is less obvious in hematology in view of studies published on adapted physical activity . Adapted physical activity seems to provide a survival benefit in diffuse large cell B lymphoma however the number remains too low in this histology.

Sarcopenia is an often-underestimated event and is associated with older age, co-morbidities, increased infectious complications, and early mortality.

Correcting sarcopenia through appropriate physical activity could reduce its negative prognostic impact.

The aim of the study is to increase the event-free survival of patients in the RCHOP and adapted physical activity arm by 15% compared to the standard arm.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard

Group Type: NO_INTERVENTION

No interventions assigned to this group

APA

• During the first 3 cures, 3 APA sessions will be offered per week:

• 2 sessions of anaerobic type of 1 hour with muscle strengthening, stretching, flexibility and balance, supervised in the room,
• 1 aerobic type exercise session of 1.5 hours (Nordic walking: outdoors) or a 3rd indoor session if not possible,
• + home exercise book if the patient so wishes with record the time in minutes per session and the intensity felt and the modalities of the exercises carried out.
• During the 5 remaining cycles, 3 APA sessions will be offered per week:

• 1 session of 1 hour in an anaerobic exercise room (muscle strengthening, stretching, flexibility, balance) supervised,
• 1 session of anaerobic exercise per week in autonomy at home (with exercise book),
• 1 or more session per week of one hour of walking or cycling independently at home (aerobic effort) with declaration in the logbook of the intensity of exertion felt and the time in minutes per session.

Group Type: EXPERIMENTAL

Adapted physical activity

Intervention Type: OTHER

APA sessions during chemotherapy with aerobic and anaerobic sessions on site and at home (+ home exercises book if the patient so wishes)

Interventions

Adapted physical activity

APA sessions during chemotherapy with aerobic and anaerobic sessions on site and at home (+ home exercises book if the patient so wishes)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patient with diffuse large-cell B lymphoma regardless of the WHO 2016 classification subtype, or low-grade B lymphoma immediately transformed into high-grade B lymphoma (follicular lymphoma of the marginal zone, MALT, lymphocytic, lympho-plasma cells),

2. Treatment naïve or having benefited from 2 cycles of chemotherapy (prephase or COP and cycle n ° 1 of RCHOP) if Performance Status> 3 linked to hemopathy and reversible (≤ 2)

3. Aged ≥ 65 years old,

4. Eligible for treatment with RCHOP, regardless of the IPI score adjusted for age,

5. Performance Status ≤ 2,

6. Patient affiliated to a social security scheme,

7. Patient who has given written consent before any specific procedure related to the study

Exclusion Criteria

1. Any other type of lymphoma (T lymphoma, Burkitt's lymphoma, non-transformed low-grade B lymphoma, etc.),

2. Cerebral or meningeal damage related to hemopathy,

3. Acquired or congenital motor or sensory deficit which does not allow the completion of APA sessions,

4. Uncontrolled arterial hypertension,

5. Disabling heart or respiratory failure not allowing the completion of APA sessions,

6. Disabling osteo-articular or muscular pathology,

7. LVEF <50%,

8. Patient having received 3 or more cycles of 1st line chemotherapy,

9. Pregnancy or breastfeeding,

10. Active viral infection: hepatitis B, C and HIV,

11. Persons deprived of their liberty or under guardianship

12. Dementia, mental alteration or psychiatric pathology which could compromise the patient's informed consent and / or compliance with the protocol and follow-up of the trial,

13. Patient who can't follow protocol for psychological, social, family or geographic reasons

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weprom

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katell LE DÛ, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Victor Hugo/Centre Jean Bernard

Locations

CHU Jean Minjoz

Besançon, , France

Site Status: NOT_YET_RECRUITING

Clinique Victor Hugo / Centre Jean Bernard

Le Mans, , France

Site Status: RECRUITING

CHRU Nancy

Nancy, , France

Site Status: NOT_YET_RECRUITING

Hôpital Privé du Confluent

Nantes, , France

Site Status: RECRUITING

CH Perpignan

Perpignan, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Magali BALAVOINE

Role: CONTACT

m.balavoine@weprom.fr

0241682940 ext. 0033

Facility Contacts

Adrien CHAUCHET, MD

Role: primary

achauchet@chu-besancon.fr

0381669024 ext. 0033

Katell LE DÛ, MD

Role: primary

k.ledu@cjb72.org

0243391300 ext. 0033

Pierre FEUGIER, MD

Role: primary

p.feugier@chru-nancy.fr

0383153282 ext. 0033

Sophie LEBOUVIER-SADOT, MD

Role: primary

sophie.sadot.lebouvier@groupeconfluent.fr

0228272118 ext. 0033

Virginie ROLAND, MD

Role: primary

virginie.roland@ch-perpignan.fr

0468618907 ext. 0033

References

Dubu J, Boyas S, Roland V, Landry S, Septans AL, Balavoine M, Bourgeois H, Pointreau Y, Denis F, Letellier C, Le Du K. Physical Activity Program for the Survival of Elderly Patients With Lymphoma: Study Protocol for Randomized Phase 3 Trial. JMIR Res Protoc. 2022 Nov 25;11(11):e40969. doi: 10.2196/40969.

Reference Type: DERIVED

PMID: 36427234 (View on PubMed)

Other Identifiers

2019-A02248-49

Identifier Type: OTHER

Identifier Source: secondary_id

WP-2020-03

Identifier Type: -

Identifier Source: org_study_id